510(k) K233423

Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System by Tyber Medical, LLC — Product Code HRS

K233423 is an FDA 510(k) premarket notification submitted by Tyber Medical, LLC for the device "Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System". The FDA issued a decision of Substantially Equivalent on December 21, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Tyber Medical, LLC has at least 10 other 510(k) clearances on record.